Endovascular ThrombectomyFACTOR-LVONCT07740018
Factors Affecting Clinical and Radiological Outcome in Endovascular Management of Acute Ischemic Stroke Due to Large Vessel Occlusion
A study testing endovascular thrombectomy in people with Endovascular Thrombectomy, run by Sohag University at 1 site in Egypt.
Trial summary
Acute ischemic stroke (AIS), particularly if it is caused by a large-vessel occlusion (LVO), is a severe and life-threatening disease. Endovascular therapy (EVT) has rendered safe and effective treatment of AIS due to LVO possible, and new thrombolytic agents and neuroprotectants could soon complement pharmacological… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endovascular Thrombectomy
- What is being tested?
- endovascular thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Criteria (Applicable to All Time Windows)
- Age ≥ 18 to 80 years old.
- Acute ischemic stroke due to large vessel occlusion (LVO) presenting within 24 hours from symptom onset or last known well. Occlusion involving one of the following vessels:
- internal carotid artery (ICA)
- M1 segment of the middle cerebral artery (MCA)
- A1 segment of the anterior cerebral artery (ACA)
Show all 15Show fewer
- P1 segment of the posterior cerebral artery (PCA)
- Basilar artery (BA)
- V4 segment of the vertebral artery (VA)
- National Institutes of Health Stroke Scale (NIHSS) score ≥ 6. Patients Presenting Within 0-6 Hours from Symptom Onset or Last Known Well ,
- Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6.
- Patients presenting 6-24 hours from the last known well, imaging eligibility based on :
- Estimated ischemic core volume < 70 mL.
- Ratio of critically hypoperfused tissue to ischemic core (mismatch ratio) ≥ 1.8.
- Absolute volume of potentially salvageable tissue (Diffusion to flair mismatch volume) ≥ 15 mL.
Who cannot join
- • Patients with stroke resulting from etiologies other than LVO.
- Individuals with a history of previous strokes.
- Hemorrhagic stroke
- Large established infarction (e.g., ASPECTS < 6 for patients within the early time window or imaging findings not meeting eligibility criteria in the late window).
- Patients presenting 6-24 hours from the last known well who do not meet advanced imaging selection criteria (e.g., DEFUSE 3 or DAWN eligibility criteria).
- Pre-stroke disability with a modified Rankin Scale (mRS) score ≥2.
- Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Faculty of Medicine
Sohag, 82516
sohag university sohag university faculty of medicine, 0934602963, ethics@med.sohag.edu.eg
About this study
Acute ischemic stroke (AIS), particularly if it is caused by a large-vessel occlusion (LVO), is a severe and life-threatening disease. Endovascular therapy (EVT) has rendered safe and effective treatment of AIS due to LVO possible, and new thrombolytic agents and neuroprotectants could soon complement pharmacological AIS therapy. These treatments are highly time dependent. Hence, the overarching goal in the management of patients with AIS is to rapidly and safely transfer, diagnose, and treat patients with AIS (1).
The only available 2 treatment options are intravenous alteplase and endovascular therapy (mechanical clot removal), both of which are highly time dependent. Thus, rapid patient transfer, diagnosis, and treatment are crucial, and time-consuming imaging methods and overly selective treatment selection criteria should be avoided (2).
Read more
Imaging is crucial for AIS management, as it confirms the diagnosis and guides treatment, with intravenous tissue plasminogen activator (alteplase) and/or EVT, the 2 evidence-based treatment strategies for AIS. Every 30-min delay in recanalization decreases the chance of a good functional outcome by 8% to 14% (3).
Clinical outcome after large-vessel occlusive strokes depends on admitting clinical condition, successful recanalization, and robust collateral circulation. However, predicting successful recanalization and quantifying collateral status in the acute setting remain elusive (4).
Successful recanalization has many predictive factors. Strong evidence supports increasing clot length being associated with poor recanalization. Current imaging techniques completed in the acute setting suggest that clot length can be estimated with a clot burden score (5).
Studies consistently show that independent predictors in clinical outcome remain the patient's admission clinical condition as evaluated by baseline NIH Stroke Scale (NIHSS) scores and ischemic lesion volume. Emphasis on lesion volume suggested that stroke mechanism, particularly lacunar strokes with their smaller ischemic volumes, could be an independent predictor for favorable clinical outcome. However, predicting clinical outcome with stroke mechanism, particularly in large vessel occlusions (LVO), remains elusive (6).
As thrombus origin site (i.e., vein, artery, or heart) is thought to play a role in clot composition, cardioembolic and paradoxical strokes with their greater fibrin content and red cells were thought to be more susceptible to fibrinolysis than heterogeneous, chronic thrombotic arterial plaques formed in artery-to-artery strokes. However, studies continue to show that stroke mechanism does not influence recanalization or clinical outcome after intravenous rt-PA (IVtPA) (7).
Radiological signs that are readily available on a patient's index CT scan have generated interest as predictors for patients undergoing EVT for LVO AIS. For example, poor baseline collateral flow status and Alberta Stroke Program Early CT Score (ASPECTS), assessed via CT angiography, are associated with a larger ischemic core and worse functional outcomes. Other radiological variables which have been investigated include clot characteristics including clot length, density, surface phenotype, truncal versus branch-type occlusions and the presence of a meniscus sign. Further radiological variables that have been studied pertain to vascular anatomy and include parameters that quantify vascular tortuosity such as the aortic arch type (8).
Despite advances in the management of acute ischemic stroke due to large-vessel occlusion, significant variability still exists in both clinical and radiological outcomes among patients. Moreover, the relative contribution and interaction of different clinical and imaging predictors in determining treatment success and functional recovery remain not fully established. In addition, there is still no complete consensus regarding the most reliable predictors of recanalization and favorable outcomes in the acute setting, particularly in relation to thrombus characteristics, collateral status, and vascular anatomy (9).
Therefore, this study aims to evaluate factors affecting clinical and radiological outcome in management of acute ischemic stroke due to large vessel occlusion.
- Conditions
- Endovascular Thrombectomy
- Being tested
- endovascular thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular thrombectomyProcedure or surgery
Following radiological assessment and confirmation of eligibility, patients will be transferred directly to the angiography suite for endovascular treatment. Mechanical thrombectomy will be performed by direct aspiration, stent retriever thrombectomy, or a combined approach (Solumbra technique), according to the angiographic findings, vascular anatomy, and operator judgment. The procedural goal will be to achieve successful reperfusion while minimizing procedure-related complications.
Following the procedure, patients will be admitted to the stroke unit or neurocritical care unit for close neurological and hemodynamic monitoring. Blood pressure, neurological status, and access-site complications will be monitored according to institutional stroke protocols . Antithrombotic therapy will be initiated or resumed after follow-up imaging confirms the absence of clinically significant intracranial hemorrhage, in accordance with current stroke management guidelines and the underlying stroke
| Study group | Role | What they receive |
|---|---|---|
| endovascular thrombectomy | Active comparator | Not described Receives: Procedure: endovascular thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early neurological improvement
Neurological status will be evaluated using the National Institutes of Health Stroke Scale (NIHSS). Early neurological improvement is defined as a reduction of ≥4 points in NIHSS score or an NIHSS score of 0-1.
Measured: 24 hours after procedure
modified ranken scale
Functional outcome will be assessed using the modified Rankin Scale (mRS). A favorable outcome is defined as an mRS score of 0-2 at 90 days following endovascular treatment. The association between baseline clinical, radiological, procedural factors and functional outcome will be analyzed.
Measured: 90 days
successful angiographic reperfusion
Successful reperfusion will be assessed using the modified Thrombolysis in Cerebral Infarction (mTICI) grading system. Successful reperfusion is defined as mTICI grade 2b, 2c, or 3 at the end of the endovascular procedure.
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endovascular ThrombectomyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed AHmed Kassem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740018
- Sponsor's protocol ID
- soh-med--26-7-4MD
- Acronym
- FACTOR-LVO
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ospel JM, Holodinsky JK, Goyal M. Management of Acute Ischemic Stroke Due to Large-Vessel Occlusion: JACC Focus Seminar. J Am Coll Cardiol. 2020 Apr 21;75(15):1832-1843. doi: 10.1016/j.jacc.2019.10.034.
PubMed 32299595Thomalla G, Boutitie F, Ma H, Koga M, Ringleb P, Schwamm LH, Wu O, Bendszus M, Bladin CF, Campbell BCV, Cheng B, Churilov L, Ebinger M, Endres M, Fiebach JB, Fukuda-Doi M, Inoue M, Kleinig TJ, Latour LL, Lemmens R, Levi CR, Leys D, Miwa K, Molina CA, Muir KW, Nighoghossian N, Parsons MW, Pedraza S, Schellinger PD, Schwab S, Simonsen CZ, Song SS, Thijs V, Toni D, Hsu CY, Wahlgren N, Yamamoto H, Yassi N, Yoshimura S, Warach S, Hacke W, Toyoda K, Donnan GA, Davis SM, Gerloff C; Evaluation of unknown Onset Stroke thrombolysis trials (EOS) investigators. Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data. Lancet. 2020 Nov 14;396(10262):1574-1584. doi: 10.1016/S0140-6736(20)32163-2. Epub 2020 Nov 8.
PubMed 33176180Huo X, Sun D, Raynald, Jia B, Tong X, Wang A, Ma N, Gao F, Mo D, Ma G, Amin S, Ren Z, Miao Z; ANGEL-ACT study group. Endovascular Treatment in Acute Ischemic Stroke with Large Vessel Occlusion According to Different Stroke Subtypes: Data from ANGEL-ACT Registry. Neurol Ther. 2022 Mar;11(1):151-165. doi: 10.1007/s40120-021-00301-z. Epub 2021 Nov 20.
PubMed 34800279
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Clinical and Radiological Outcome in Endovascular Management of Acute Ischemic Stroke Due to Large Vessel Occlusion
- ClinicalTrials.gov ID
- NCT07740018
- Acronym / sponsor ID
- FACTOR-LVO / soh-med--26-7-4MD
- Conditions
- Endovascular Thrombectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute ischemic stroke (AIS), particularly if it is caused by a large-vessel occlusion (LVO), is a severe and life-threatening disease. Endovascular therapy (EVT) has rendered safe and effective treatment of AIS due to LVO possible, and new thrombolytic agents and neuroprotectants could soon complement pharmacological AIS therapy. These treatments are highly time dependent. Hence, the overarching goal in the management of patients with AIS is to rapidly and safely transfer, diagnose, and treat patients with AIS (1).
The only available 2 treatment options are intravenous alteplase and endovascular therapy (mechanical clot removal), both of which are highly time dependent. Thus, rapid patient transfer, diagnosis, and treatment are crucial, and time-consuming imaging methods and overly selective treatment selection criteria should be avoided (2).
Imaging is crucial for AIS management, as it confirms the diagnosis and guides treatment, with intravenous tissue plasminogen activator (alteplase) and/or EVT, the 2 evidence-based treatment strategies for AIS. Every 30-min delay in recanalization decreases the chance of a good functional outcome by 8% to 14% (3).
Clinical outcome after large-vessel occlusive strokes depends on admitting clinical condition, successful recanalization, and robust collateral circulation. However, predicting successful recanalization and quantifying collateral status in the acute setting remain elusive (4).
Successful recanalization has many predictive factors. Strong evidence supports increasing clot length being associated with poor recanalization. Current imaging techniques completed in the acute setting suggest that clot length can be estimated with a clot burden score (5).
Studies consistently show that independent predictors in clinical outcome remain the patient's admission clinical condition as evaluated by baseline NIH Stroke Scale (NIHSS) scores and ischemic lesion volume. Emphasis on lesion volume suggested that stroke mechanism, particularly lacunar strokes with their smaller ischemic volumes, could be an independent predictor for favorable clinical outcome. However, predicting clinical outcome with stroke mechanism, particularly in large vessel occlusions (LVO), remains elusive (6).
As thrombus origin site (i.e., vein, artery, or heart) is thought to play a role in clot composition, cardioembolic and paradoxical strokes with their greater fibrin content and red cells were thought to be more susceptible to fibrinolysis than heterogeneous, chronic thrombotic arterial plaques formed in artery-to-artery strokes. However, studies continue to show that stroke mechanism does not influence recanalization or clinical outcome after intravenous rt-PA (IVtPA) (7).
Radiological signs that are readily available on a patient's index CT scan have generated interest as predictors for patients undergoing EVT for LVO AIS. For example, poor baseline collateral flow status and Alberta Stroke Program Early CT Score (ASPECTS), assessed via CT angiography, are associated with a larger ischemic core and worse functional outcomes. Other radiological variables which have been investigated include clot characteristics including clot length, density, surface phenotype, truncal versus branch-type occlusions and the presence of a meniscus sign. Further radiological variables that have been studied pertain to vascular anatomy and include parameters that quantify vascular tortuosity such as the aortic arch type (8).
Despite advances in the management of acute ischemic stroke due to large-vessel occlusion, significant variability still exists in both clinical and radiological outcomes among patients. Moreover, the relative contribution and interaction of different clinical and imaging predictors in determining treatment success and functional recovery remain not fully established. In addition, there is still no complete consensus regarding the most reliable predictors of recanalization and favorable outcomes in the acute setting, particularly in relation to thrombus characteristics, collateral status, and vascular anatomy (9).
Therefore, this study aims to evaluate factors affecting clinical and radiological outcome in management of acute ischemic stroke due to large vessel occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endovascular thrombectomy | Active comparator | Procedure: endovascular thrombectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- General Criteria (Applicable to All Time Windows)
- internal carotid artery (ICA)
- M1 segment of the middle cerebral artery (MCA)
- A1 segment of the anterior cerebral artery (ACA)
- P1 segment of the posterior cerebral artery (PCA)
Key exclusion criteria (7 listed)
- • Patients with stroke resulting from etiologies other than LVO.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular thrombectomyFollowing radiological assessment and confirmation of eligibility, patients will be transferred directly to the angiography suite for endovascular treatment. Mechanical thrombectomy will be performed by direct aspiration, stent retriever thrombectomy, or a combined approach (Solumbra technique), according to the angiographic findings, vascular anatomy, and operator judgment. The procedural goal will be to achieve successful reperfusion while minimizing procedure-related complications. Following the procedure, patients will be admitted to the stroke unit or neurocritical care unit for close neurological and hemodynamic monitoring. Blood pressure, neurological status, and access-site complications will be monitored according to institutional stroke protocols . Antithrombotic therapy will be initiated or resumed after follow-up imaging confirms the absence of clinically significant intracranial hemorrhage, in accordance with current stroke management guidelines and the underlying stroke | Procedure or surgery | endovascular thrombectomy |
Primary outcome
Early neurological improvement
Time frame: 24 hours after procedure
Neurological status will be evaluated using the National Institutes of Health Stroke Scale (NIHSS). Early neurological improvement is defined as a reduction of ≥4 points in NIHSS score or an NIHSS score of 0-1.
modified ranken scale
Time frame: 90 days
Functional outcome will be assessed using the modified Rankin Scale (mRS). A favorable outcome is defined as an mRS score of 0-2 at 90 days following endovascular treatment. The association between baseline clinical, radiological, procedural factors and functional outcome will be analyzed.
successful angiographic reperfusion
Time frame: immediately after procedure
Successful reperfusion will be assessed using the modified Thrombolysis in Cerebral Infarction (mTICI) grading system. Successful reperfusion is defined as mTICI grade 2b, 2c, or 3 at the end of the endovascular procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Results publication: PubMed 32299595Ospel JM, Holodinsky JK, Goyal M. Management of Acute Ischemic Stroke Due to Large-Vessel Occlusion: JACC Focus Seminar. J Am Coll Cardiol. 2020 Apr 21;75(15):1832-1843. doi: 10.1016/j.jacc.2019.10.034.
- Results publication: PubMed 33176180Thomalla G, Boutitie F, Ma H, Koga M, Ringleb P, Schwamm LH, Wu O, Bendszus M, Bladin CF, Campbell BCV, Cheng B, Churilov L, Ebinger M, Endres M, Fiebach JB, Fukuda-Doi M, Inoue M, Kleinig TJ, Latour LL, Lemmens R, Levi CR, Leys D, Miwa K, Molina CA, Muir KW, Nighoghossian N, Parsons MW, Pedraza S, Schellinger PD, Schwab S, Simonsen CZ, Song SS, Thijs V, Toni D, Hsu CY, Wahlgren N, Yamamoto H, Yassi N, Yoshimura S, Warach S, Hacke W, Toyoda K, Donnan GA, Davis SM, Gerloff C; Evaluation of unknown Onset Stroke thrombolysis trials (EOS) investigators. Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data. Lancet. 2020 Nov 14;396(10262):1574-1584. doi: 10.1016/S0140-6736(20)32163-2. Epub 2020 Nov 8.
- Results publication: PubMed 34800279Huo X, Sun D, Raynald, Jia B, Tong X, Wang A, Ma N, Gao F, Mo D, Ma G, Amin S, Ren Z, Miao Z; ANGEL-ACT study group. Endovascular Treatment in Acute Ischemic Stroke with Large Vessel Occlusion According to Different Stroke Subtypes: Data from ANGEL-ACT Registry. Neurol Ther. 2022 Mar;11(1):151-165. doi: 10.1007/s40120-021-00301-z. Epub 2021 Nov 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular thrombectomy in people with Endovascular Thrombectomy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed ahmed kassem, assistant lecturer (00201098003153, mohamed011152@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early neurological improvement (time frame: 24 hours after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07740018, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.